Bosentan in clinical practice for treating digital and other ischemic ulcers in Spanish patients with systemic sclerosis: IBER-DU Cohort Study

The Journal of Rheumatology, 06/06/2011

Ivorra JAR et al. – Previously reported results of bosentan efficacy in DU management are reproducible in clinical practice. This efficacy is maintained in the longterm followup. Bosentan treatment was well tolerated and adverse events were comparable with those observed in previous reports.

Methods

Multicenter, noninterventional retrospective cohort study

Data collected retrospectively from patients with DU, with or without PAH, who were initiating bosentan therapy in 2003 (n = 26) or 2004 (n = 41) and followed until May 2005

Data were obtained from centers prescribing bosentan

Relevant measures included number of DU, occurrence of new DU, overall DU clinical status (improved, stabilized, worsened), and bosentan-associated AEs

Results

67 patients with SSc and DU or other ulcers included

PAH was also present in 12 patients (18%)

At start of bosentan treatment, median number of DU per patient was 3.0